Non-sliding and non-sutured contact lens system for ophthalmic procedures

RELATED APPLICATIONS

This Application is a Continuation of patent application Ser. No. 15/497,827, filed 26 Apr. 2017, which was based upon Provisional Patent Application Ser. No. 62/329,292, filed on 29 Apr. 2016.

FIELD OF THE INVENTION

The present invention is directed to the field of ophthalmic surgical intervention, and particular to contact lens used in ophthalmic surgeries.

More in particular, the present invention is directed to corneal (and macular) contact lenses, as well as gonioprisms, used in vitreoretinal surgeries (procedures), which allow a surgeon to visualize the macula and other structures of the eye under surgery at high magnification.

In addition, the present invention is directed to contact lenses used in ophthalmic procedures which are configured with an anchoring mechanism which stabilizes and centers the lens on the cornea of the eye (or other desired site of procedure) in a “hands-free” manner without the need for monitoring and manual positioning of the contact lens during ophthalmic procedures.

Further, the subject system is directed to a contact lens anchoring system which does not require suturing for stabilization and centration during the ophthalmic procedure, and thus is free of superficial bleeding from the conjunctiva caused by the suturing.

The present invention is further directed to a non-sutured and hands-free contact lens anchoring system for ophthalmic surgeries which effectively stabilizes and centers the lens on the cornea of the eye during surgery and which is prevented from sliding on the area of interest by a number of microstructures strategically placed on the bottom of either the contact lens itself or the bottom of a non-sutured contact lens holder. The microstructures are gently pressed down into contact with the superficial layer of the eye tissue during the surgery, thus temporarily anchoring the contact lens to the cornea and are easily removed (or lifted away) from the eye when the procedure is completed.

Additionally, the present system is directed to a suture free, non-sliding stabilization anchoring system for a corneal (or macular) contact lens, as well as gonioprism contact lens, used in vitreoretinal surgeries, which is configured with microstructures located on the bottom of either the contact lens or the contact lens holder, and which gently indent into the superficial cornea during the procedure to temporarily anchor the contact lens or lens holder to the cornea without injuring the eye tissues.

BACKGROUND OF THE INVENTION

Corneal contact lenses are a critical part of vitreoretinal surgery, especially macular surgery. The contact lenses allow a surgeon to visualize the macular as well as other structures of the eye at high magnification. Surgeons typically employ a separate lens that can be placed directly on the eyeball and allow focusing to be extended to the retina and other areas in the back of the eyeball.

In order to be effective, a contact lens must be stably positioned and centered on the cornea of the eye at the site of the surgery. This is difficult to achieve due to the cornea curved contouring. The slipperiness is made worse by the use of viscous coupling agents (such as, for example, viscoelastics or hydroxymethyl cellulose), which are used to avoid bubble formation beneath the contact lens during the surgery.

The lens placed on the eyeball floats on a thin layer of fluid and tends to slide about the surface of the eye. In order to overcome the sliding displacement and to hold the lens in place, a surgeon or a surgeon's assistant constantly monitors the lens position and uses a rod or other extension (handle) to push the lens back to a desired location. In order to perform this task, the surgeon or surgeon's assistant must have a profound experience in vitreoretinal surgery which is not always the case.

For example, U.S. Pat. No. 5,070,290, describes the gonioscopy, which is a technique used for viewing inner portions (such as the retina and the anterior chamber angle) of the eye for evaluation, management, and classification of normal and abnormal structures of the eye. The gonioscopy technique uses devices known as gonioscopes to enhance visibility of the trabecular meshwork and anterior chamber angle during surgical procedures. The gonioscope is hand-held by a surgeon in place over the patient's cornea while he/she performs the surgical procedure.

The gonioscope described in U.S. Pat. No. 8,070,290 includes the Hill gonioprism positioned on a patient's eye. The gonioscopic optical element, which includes one or several lens, such as optical prism(s), is received in a lens retainer, and a handle or a grip is attached to the lens retainer. During the surgical procedure, the gonioscopic optical element is positioned over or on the patient's eye, e.g. the cornea of the eye.

A light source is used during the surgery which emits light toward the patient's eye. The light source may be configured such that light from the source illuminates the patient's eye, the anterior chamber, and the eye structures near the anterior chamber, e.g. trabecular meshwork, such that one or more of these structures reflect(s) light incident from the light source.

The light source and the prism(s) is (are) arranged in such a fashion that the light from the light source is reflected by the patient's eye (or specific optical structures), traverses the gonioscopic prism(s), and is redirected, e.g., refracted and diffracted, by the gonioscopic prisms. An image is formed of at least part of the patient's eye and this image is viewed using a microscope.

The handle of the gonioscope described in '290 patent is used to stabilize and centralize the entire gonioscope structure. This arrangement generally requires assistance of a surgeon assistant to manipulate the handle of the gonioscope during the procedure.

Landers has improved upon the gonioscope prism requiring manual manipulation of the handle during the ophthalmic procedure surgery, and provided a “hand-free” solution for the problem which eliminates the need for a surgeon assistant to manually stabilize and centralize the contact lens.

The Landers' system uses a lens ring which circumferentially envelopes sides of the contact lens, and serves as the lens holder. To stabilize and centralize the contact lens at the desired site during the procedure, the lens ring is secured to the conjunctiva/sclera with a pair of fixation sutures. The contact lens is placed inside the lens ring which remains in place by the fixation sutures, and thus, the contact lens is maintained in place and sutured throughout the duration of the macular surgery.

Fixation sutures, however, are not welcomed by a majority of ophthalmologists, especially glaucoma surgeons, due to traumatic effects of the fixation sutures to the cornea or sclera of the eye. In addition to the traumatic nature of the fixation sutures (which typically cause bleeding which can obscure view of the surgical site), if the sutures are excessively tight, the cornea can be disturbed and the sutures may break during the surgery, which is definitely a disadvantage of the suturing approach. On the other hand, if the sutures are too loose, the displacement of lens may occur, which can undermine the surgery efficiency.

Since the Landers development, various solutions for “suture-less” contact lens stabilization have been developed. For example, as presented in U.S. Pat. No. 5,963,301, the lens is constructed with a flange that is shaped to conform to the general curvature of an average eye. In order to be attached to the eye surface, and thus stabilizing the lens in place, the flange is formed with a number of peripheral openings or recesses sized to accommodate various types of instruments to be inserted into the eye during the surgery. The flange is formed with fittings to which a vacuum is applied in order to pull the flange into contact with the sclera of the eye by creating a vacuum between the flange and eye to enhance holding the lens device in position.

Another method for overcoming the problem of contact lens movement during surgery is disclosed in U.S. Pat. No. 6,120,147 where the lens are replaced with flexible lens having a relatively flexible flange which is fixed in place by capillary action.

U.S. Patent Application Publication No. 2014/0307229 and related U.S. Pat. No. 9,339,184 describe a contact lens for vitreoretinal surgery where a contact lens assembly has a central lens and a circumscribing flange. The lens has an eye contact surface shaped generally to a radius of curvature of a cornea of an eye. The flange comprises a sterile sponge-like liquid absorbent flexible material having a central aperture for fitting snuggly about an outer circumference of the lens and extending radially outward therefrom.

During the procedure, the lens is mated with a flange and the lens/flange assembly is then placed on the wetted eye of a patient. Additional wetting compound, such as sterile saline solution, is then spread onto the flange until the flange is generally situated. The lens can then be moved as necessary for viewing and the wetted flange holds the lens in a desired position.

It has been found that most of the prior art devices slide off of the cornea during the surgery. The surgeon, or the surgeon's assistant, must push the lens back to the center of the cornea a number of times during critical steps of the surgery. This may cause loss of the surgical field at a crucial moment. Thus, the suture-less systems currently available, are not preferred by many surgeons. The surgeons use the sutured lens ring even though it takes additional time and causes superficial bleeding from the conjunctiva.

It is highly desirable to provide a suture-free and hands-free non-sliding corneal contact lens stabilization and anchoring system for vitreoretinal surgery which does not require monitoring and manual positioning of the lens during the surgery and which provides hands-free effective stabilization and centralization of the lens during a surgical procedure in trauma-free manner.

One of the important topics discussed among glaucoma surgical specialists is micro invasive glaucoma surgery, further referred to herein as MIGS. The MIGS refers to a group of relatively recent glaucoma surgery techniques that are gentler and involve less tissue disruption than traditional glaucoma surgeries (such as trabeculectomy and shunts).

The glaucoma specialists indicate that there is a significant learning curve in order to master MIGS technique. Operating directly on the tiny trabecular meshwork is challenging. Obtaining visualization of the angle is the most difficult part of the learning curve and the key to mastering this surgery. The critical angle of the peripheral cornea may cause total internal reflectivity of light. For that reason, special contact lenses are needed to allow visualization of the angle structures.

Even with a surgical gonioprism, the critical angle surgery is difficult to perform. Mastering the usage of the current surgical gonioprism is a significant barrier for many surgeons. In order to visualize the angle structures, a surgeon rotates the patient's head to the side by 30°, to the microscope 30°, and to steady a hand-held surgical gonioprism on the cornea with their non-dominant hand (as shown, for example, in U.S. Pat. No. 8,070,290). This requires a significant amount of practice and steady hands. The surgeon cannot learn the technical steps of the MIG surgery, such as implanting the stent or cutting into the trabecular meshwork, until they can consistently obtain a steady view of the angle.

Glaucoma surgeons are universally opposed to placing fixation sutures. They do not want to cause any trauma to the cornea or sclera of the eye. Simplifying and improving the visualization of the critical angle during the surgery, without causing tissue injury by fixating sutures can remove the barriers that are currently limiting adoption of this newest type of glaucoma surgery, i.e., MIGS.

U.S. Patent Application Publication No. 2012/0099077 to Abt describes an ophthalmic optics (lens) which includes an aspheric anterior surface and a posterior surface having a shape substantially corresponding to the shape of a human cornea. In order to support the lens on the cornea, Abt uses a surrounding flange. Adhesive, weights or fibers (for the lens stabilization) are embedded in the tabs of the flange for registering with the sclera to create stabilization forces by the tabs' interaction with the sclera.

In Abt, the stabilizing structures (which are embedded in the tabs of the flange) do not come in contact with the tissues of the eye at the operation site. They are positioned above the eye tissues at the sclera (and thus are laterally displaced from the operation site) and “float” above the sclera area separated from the sclera tissues through the layer of the tear film and viscous layer. This “floating” on the slippery film does not provide a reliable stabilization of the lens at the operation site in Abt arrangement.

Abt's stabilizing mechanism produces shear forces displaced laterally from the cornea area and applied to the sclera (away from the cornea), and is neither formed integrally with the bottom surface of the lens nor extends vertically downward from the bottom of the lens into contact with the procedure site (such as the cornea).

The only structure in Abt system which does penetrate through the tear film of the eye are trocar cannulas. However, Abt does not consider the trocar cannulas as a mechanism for securing the optical lens to the eye of the patient. Abt emphasizes that the fastening means include packing material and/or mechanical fasteners, which are used to secure the optical lens to the patient's eye to stabilize the optical element on the eye and permit the appropriate insertion of the trocar cannulas. Thus, in Abt, trocar cannulas by themselves do not constitute the anchoring mechanism, and other fastening elements are used which facilitate the insertion of the trocar cannulas.

In Abt, the trocar cannulas are dimensioned in the mm range, and penetrate deep into sclera area. It is understood that such trocar cannulas dimensions are dictated by the operational requirements, however, they create a highly traumatic action on the tissues of the eye.

Another disadvantage of Abt is that the lens “is self-retaining on the eye through capillary attraction”. The stability of the lens in Abt relies on a capillary attraction, which is not desirable since the capillary attraction forces tend to pull blood and air bubbles beneath the contact lens during surgery. This phenomenon can impair the surgeon's visualization during critical moments of surgical procedure.

It would be highly desirable to provide a stand-alone mechanism which is integral with the optics and which creates vertical forces registered with the cornea area for directly stabilizing the contact lens on the cornea where the contact lens can be stabilized and centralized over the surgical area of the eye in a suture free non-sliding manner without the need for manual repositioning and centralization of the contact lens during the operation.

It also would be desirable to provide ophthalmic optics equipped with microstructured anchoring elements which are formed integrally with the bottom of the contact lens or in close proximity to the periphery of the contact lens so that when the contact lens is placed on the cornea, the microstructured anchoring elements pass vertically downward to penetrate through the tear film and viscous layer on the cornea, and come into direct contact with the cornea, i.e., in registration with the operation site to provide a vertical compression force applied to the cornea by the bottoms of the microstructures, which creates an increased friction between the microstructures and the cornea, which prevents lens from sliding from the cornea, thus forming a highly reliable mechanism of anchoring the lens in position during the operation.

SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a contact lens assembly for ophthalmic procedures which would attain a non-sliding non-sutured hand-free operation for the lens stabilization and centralization during a vitreoretinal surgery.

It is another object of the present invention to provide a contact lens assembly equipped with an anchoring system capable of hands-free stabilization and centralization of the contact lens assembly at a desired site of procedure in a non-sutured trauma-reduced manner.

In one aspect, the present invention is directed to a contact lens assembly for ophthalmic procedures, which comprises an optical element (such as a contact lens) and an anchoring mechanism formed on the eye contact surface. The anchoring mechanism is configured with microstructures disposed at predetermined positions on the eye contact surface of the optical element, and creates an anchoring action for the optical element at a desired procedure site when the microstructures are brought in contact with tissues of the eye during an ophthalmic procedure. Specifically, during the ophthalmic procedure, the optical element is placed on the desired procedure site with the microstructures in contact with superficial layer of the eye cornea.

The microstructures of the anchoring mechanism may have different forms, and may include, for example, micro-pins, micro-grips, micro-barbs, micro-needles, textured micro-elements, etc., and combinations thereof, with the important consideration being that they provide a friction force between the contact lens assembly and the eye's tissues.

The microstructures of the anchoring mechanism extend from the eye contact surface of the optical element a length not exceeding 1 mm in order to prevent a deep penetration in the eye's tissues.

The microstructures may be attached to the eye contact surface by numerous means, such as, for example, threaded connection, adhesion, gluing, pressing, thermo-soldering, 3-D printing, etc., and combinations thereof.

The microstructures may be formed from surgical steel, polyether ether ketone (PEEK) polymer, various bio-compatible plastics, and combinations thereof.

In another aspect, the present invention is directed to a contact lens assembly for ophthalmic procedures, which comprises an optical element (which may be a corneal contact lens, as well as a gonioprism contact lens) having a bottom eye contact surface, an upper surface, and side walls extending circumferentially between a peripheral edge of the bottom eye contact surface and a peripheral edge of the upper surface.

The contact lens assembly further includes an annularly contoured optical element holder having an annularly shaped bottom surface, an annularly shaped upper surface, and outer walls extending circumferentially along and between outer edges of the annularly shaped bottom and upper surfaces, respectively, of the annularly contoured optical element holder.

The annularly contoured optical element holder further has internal walls extending circumferentially along and between inner edges of the annularly shaped bottom and upper surfaces, respectively, of the annularly contoured optical element holder. The internal walls of the annularly contoured optical element holder define a holder opening which is shaped and dimensioned in correspondence to the bottom eye contact surface of the optical element.

An anchoring mechanism is formed on the annularly shaped bottom surface of the annularly contoured optical element holder. The anchoring mechanism is configured with microstructures disposed at predetermined positions on the bottom surface of the annularly contoured optical element holder to create an anchoring friction force between the bottom surface of the annularly contoured optical element holder and the eye tissues to stabilize and centralize the contact lens assembly at a desired procedure site by bringing the microstructures in contact with tissues of the eye during an ophthalmic procedure.

During the ophthalmic procedure, the optical element is received in the holder opening of the annularly contoured optical element holder and is maintained with the bottom eye contact surface in contact with the tissues of the eye at the desired procedure site by the annularly contoured optical element holder anchored at the desired procedure site through the action of the anchoring mechanism formed on the bottom surface of the annularly contoured optical element holder.

The microstructures of the anchoring mechanism may be in numerous forms, including, for example, micro-pins, micro-grips, micro-barbs, micro-needles, textured micro-elements, etc., and combinations thereof, positioned at strategic locations on the bottom surface of the optical element holder.

The microstructures of the anchoring mechanism extend from the eye contact surface of the optical element a length not exceeding 1 mm in order to prevent deep penetration in the eye's tissues.

The microstructures are attached to the eye contact surface of the optical element holder by any of the mechanisms including, for example, threaded connection, drilling, adhesion, gluing, pressing, thermo-soldering, 3-D printing, etc., and combination thereof.

The walls of the annularly contoured optical element holder may be shaped with a cut-out portion extending a predetermined length (partially or along the entire perimeter) along the walls for surgical tool access and visualization of the desired procedure site.

The annularly contoured optical element holder may be manufactured from surgical steel, or polyether ether ketone (PEEK) polymer, or other bio-compatible polymers and plastics. The holder opening may have a diameter ranging from 9 mm to 14 mm, and specifically, for example, approximately 11.5 mm.

The optical element further includes a flange member formed on the side walls thereof and extending circumferentially along the perimeter of the side walls. A flange portion of the flange member extends from the side walls surface a predetermined distance corresponding to a width of the annularly shaped upper surface between the inner and outer edges thereof. During the ophthalmic procedure, the optical element is received in the holder opening with the flange portion positioned in contact with and supported by the annularly shaped upper surface of the annularly contoured optical element holder to restrict a downward displacement of the optical element relative to the annularly contoured optical element holder.

In another embodiment, the annularly contoured optical element holder and the optical element may be assembled together with a bonding agent (such as glue) or an interlocking tab and groove locking mechanism.

Further, there is provided a stabilization system for maintaining a contact holder lens and contact lens in a stabilized and secure position during an ophthalmic procedure when the patient tilts or inclines his/her head to negate gravity assist effects caused by the head inclining or tilting.

Still further, there is provided a contact lens assembly for opthlalmic procedures which includes an eye speculum secured with, and operationally operative with the stabilization mechanism which is secured to the lens and/or lens holder to stabilize the contact lens at a predetermined positional location during the ophthalmic procedure.

Still further there is provided a stabilizing mechanism used in conjunction with an eye speculum which has an anchoring mechanism for retaining the contact lens at a selected procedure site during the ophthalmic procedure. The stabilizing mechanism includes a plurality of microstructures located on a bottom surface of the contact lens and/or a bottom surface of the contact lens holder which is in contact with the eye of the patient during the ophthalmic procedure.

In still another aspect, the present invention is directed to a method for performing an ophthalmic procedure with the use of the non-sliding non-sutured, hands-free contact lens anchoring system.

The method includes the steps of:

configuring a contact lens assembly comprising:

(a) a contact lens having a bottom eye contact surface, an upper surface, and sidewalls extending circumferentially between an edge of the bottom eye contact surface and an edge of the upper surface,

(b) an annularly contoured lens holder having:

an annularly shaped bottom surface,

an annularly shaped upper surface,

outer walls extending circumferentially along and between outer edges of said annularly shaped bottom and upper surfaces of its annularly contoured lens holder,

internal walls extending circumferentially along and between inner edges of the annularly shaped bottom and upper surfaces of the annularly contoured lens holder and defining a holder opening therebetween. The holder opening being shaped and dimensioned in correspondence to the bottom eye contact surface of the lens, and

(c) an anchoring mechanism formed on either the bottom eye contact surface of the lens, or on the annularly shaped bottom surface of the annularly contoured lens holder, where the anchoring mechanism is configured with microstructures creating an anchoring action for the lens at a desired procedure site when the microstructures are brought in contact with tissues of an eye under an ophthalmic procedure.

The method continues with the steps of:

placing the contact lens assembly to the desired procedure site;

pressing the contact lens assembly downward to attain contact between the microstructures and the tissues of the eye under the ophthalmic procedure;

performing the ophthalmic procedure; and

upon completion of the ophthalmic procedure, lifting the contact lens assembly from the eye.

Another aspect of the subject invention is in the provision of contact lens assembly for maintaining the contact lens at a predetermined relatively fixed position during the ophthalmic procedure which includes the combination of an eye speculum and a stabilization mechanism secured to the eye speculum.

In this aspect of the subject invention, the stabilizing mechanism includes a stabilizing wire which on a lower end is fixedly attached to opposing sides of a contact lens holder and at an upper end is secured to a plate member of the eye speculum. The stabilizing wire may be formed of a malleable but somewhat resilient composition. An upper end or section of the stabilizing wire is secured to the plate member by a pair of sleeve members having appendages which may be frictionally secured to the plate member.

These and other objects of the present invention will be apparent when reviewed in conjunction with accompanying Patent Drawings in the subject Patent Application and the description of the preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

<figref idref="DRAWINGS">FIGS. 1A-1B</figref> are schematic representations of the subject contact lens (<figref idref="DRAWINGS">FIG. 1A</figref>) and contact lens holder/assembly (<figref idref="DRAWINGS">FIG. 1B</figref>) attached to the cornea of the eye during the surgical procedure;

<figref idref="DRAWINGS">FIG. 2</figref> is a schematic representation of the subject gonioprism contact lens assembly attached to the eye during the surgical procedure;

<figref idref="DRAWINGS">FIGS. 3A and 4A</figref> are representative of the subject macular contact lens, where <figref idref="DRAWINGS">FIG. 3A</figref> is a view of the subject lens from the bottom, and <figref idref="DRAWINGS">FIG. 4A</figref> is a side view of the subject contact lens, showing microstructures placed on the bottom of the contact lens;

<figref idref="DRAWINGS">FIGS. 3B and 4B</figref> show an exploded view of the subject contact lens and contact lens/holder assembly showing micro structures formed on the bottom of the lens holder, where <figref idref="DRAWINGS">FIG. 3B</figref> is a bottom view of the lens holder assembly, and <figref idref="DRAWINGS">FIG. 4B</figref> is a side view of the subject lens/holder assembly;

<figref idref="DRAWINGS">FIG. 5A</figref> shows a cross sectional view of the subject contact lens and contact lens/holder assembly showing microstructures threadingly engaged with the subject contact lens;

<figref idref="DRAWINGS">FIG. 5B</figref> shows a cross sectional view of the subject contact lens and contact lens/holder assembly showing microstructures fixedly engaged with the subject contact lens with a glue;

<figref idref="DRAWINGS">FIGS. 6A-6B</figref> show an exploded view of the gonioprism contact lens assembly, where <figref idref="DRAWINGS">FIG. 6A</figref> is a side view and <figref idref="DRAWINGS">FIG. 6B</figref> is a bottom view of the subject gonioprism contact lens assembly;

<figref idref="DRAWINGS">FIGS. 7A-7B</figref> show a side view (<figref idref="DRAWINGS">FIG. 7A</figref>) and a bottom view (<figref idref="DRAWINGS">FIG. 7B</figref>) of the subject gonioprism lens holder in an alternative embodiment;

<figref idref="DRAWINGS">FIGS. 8A-8B</figref> represent the steps of the subject surgical procedure using the subject contact lens assembly with the macular (corneal) contact lens (<figref idref="DRAWINGS">FIG. 8A</figref>) and with the gonioprism contact lens assembly (<figref idref="DRAWINGS">FIG. 8B</figref>).

<figref idref="DRAWINGS">FIG. 9</figref> is a frontal elevation view of an eye speculum used in conjunction with the subject contact lens and contact lens holder;

<figref idref="DRAWINGS">FIG. 10</figref> is frontal elevational view of a stabilization mechanism to be coupled to the eye speculum as seen in <figref idref="DRAWINGS">FIG. 9</figref>;

<figref idref="DRAWINGS">FIG. 11</figref> is a frontal elevational view of the speculum assembly showing the stabilization mechanism in assembly with the speculum; and,

<figref idref="DRAWINGS">FIG. 12</figref> is a cross-sectional view partially cut-away showing the sleeve member appendage inserted within a plate member of the speculum.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

<figref idref="DRAWINGS">FIGS. 1A and 1B</figref> show schematically the anchoring of the subject suture-free, non-sliding corneal contact lens assembly on the eye during an ophthalmic procedure. As shown in <figref idref="DRAWINGS">FIG. 1A</figref>, the subject cornea contact lens assembly <b>10</b> includes a contact lens <b>12</b> removeably attached to the eye <b>14</b> by means of anchoring system <b>16</b> (which will be detailed in further paragraphs). Alternatively, as shown in <figref idref="DRAWINGS">FIG. 1B</figref>, the subject contact lens assembly <b>10</b> for ophthalmic procedures includes the contact lens <b>12</b> and the contact lens holder <b>18</b> which receives the lens <b>12</b> and holds the entire system <b>10</b> in place during the ophthalmic procedure through the action of the anchoring system <b>20</b> on the bottom of the contact lens holder <b>18</b>.

As shown in <figref idref="DRAWINGS">FIG. 1A</figref>, the anchoring system <b>16</b> is formed on the bottom <b>22</b> of the contact lens <b>12</b> in the form of microstructures <b>24</b> which, when brought into contiguous contact with the eye <b>14</b>, secure the contact lens <b>12</b> in place for the duration of the ophthalmic procedure.

As shown in <figref idref="DRAWINGS">FIG. 1B</figref>, the anchoring system <b>20</b> is configured on the bottom <b>26</b> of the contact lens holder <b>18</b>. The anchoring system <b>20</b> is formed with microstructures <b>28</b> which, when brought in contiguous contact with the tissues of the eye <b>14</b>, maintain the contact lens holder <b>18</b> in position during the ophthalmic procedure, and thus supports the contact lens <b>12</b> at the desired site of operation.

The system <b>10</b> is a novel non-sliding corneal contact lens assembly equipped with the suture-free stabilization/anchoring system for vitreoretinal surgery which utilizes the microstructures <b>24</b> on the bottom <b>22</b> of the lens <b>12</b> or the microstructures <b>28</b> on the bottom <b>26</b> of the ring holder <b>18</b>. Microstructure <b>24</b> may be in numerous shapes, including, for example, micro-pins <b>30</b>, micro-grips, micro-barbs, micro-needles, or other textured microstructures on the bottom surface of the contact lens <b>12</b> or the contact lens holder <b>18</b>.

For the sake of simplicity and clarity of description, the microstructures <b>24</b> and <b>28</b> are described, as an example, in reference to the micro-pins <b>30</b>, although other microstructures on the bottom <b>22</b> of the lens <b>12</b> or the bottom <b>26</b> of the holder <b>18</b> are contemplated in the scope of the present invention. After the contact lens <b>12</b> is placed on the cornea <b>32</b> of the eye <b>14</b> and centered, a surgeon applies downward pressure on the contact lens <b>12</b>, which secures the lens <b>12</b> to the cornea <b>32</b>. The micro-pins <b>30</b> extend through a tear film <b>34</b> on the surface of the cornea <b>32</b> and a viscous coupling agent (solution) used during the procedure when applied to the ocular surface of the eye.

The coupling fluids applied on the surface of the tear film <b>34</b> during the procedure may be selected from a group of coupling fluids such as 2% methocel, thiol-tears gel, 1.4% sodium hyaluronate, 0.9% simple saline, and other contact solutions applicable to the purposes of the ophthalmic care using contact lens.

The micro-pins <b>30</b> extend through the tear film <b>34</b> and the viscous solution film <b>36</b> on the surface of the cornea <b>32</b>, and gently indent into the superficial cornea <b>32</b> without injuring it. A friction force is created between the lens' bottom surface and the coupling agent layer <b>36</b>, as well as superficial corneal layer <b>32</b>, by the micro-pins <b>30</b> indentation into the superficial cornea <b>32</b>, so that the contact lens <b>12</b> or the contact lens holder <b>18</b> is temporarily anchored to the cornea <b>32</b> for the duration of the ophthalmic procedure. After the ophthalmic procedure has been completed, the contact lens <b>12</b> and/or the lens holder <b>18</b> is lifted from the eye <b>14</b>.

Referring to <figref idref="DRAWINGS">FIGS. 1A and 2</figref>, the subject system <b>10</b> is also applicable for surgical gonioprism assembly <b>38</b> for glaucoma surgery, where a gonioprism contact lens <b>40</b> is used to obtain adequate visualization of the critical angle of the peripheral cornea to perform the micro invasive glaucoma surgery (MIGS) which includes implanting the stent or cutting into the trabecular meshwork. Glaucoma surgeons are generally opposed to placing fixation sutures during the glaucoma procedure in order to avoid trauma to the cornea or sclera of the eye. For this reason, the suture free system <b>38</b> of the current invention using a gonioprism contact lens <b>40</b> is highly desirable for use in ophthalmic procedures involving glaucoma surgical procedures.

As shown in <figref idref="DRAWINGS">FIG. 2</figref>, the gonioprism contact lens assembly <b>38</b> includes the gonioprism contact lens <b>40</b> and the lens holder <b>42</b>. The bottom <b>44</b> of the lens holder <b>42</b> is formed with microstructure anchoring system <b>46</b> which may be in the form of micro-pins, micro-grips, micro-barbs, micro-needles or other textured elements formed on or attached to the bottom surface <b>44</b> of the lens holder <b>42</b>. The details of the gonioprism assembly <b>38</b> will be presented in further paragraphs.

Referring to <figref idref="DRAWINGS">FIGS. 1A-1B, 3A-3B and 4A-4B</figref> showing the subject macular contact lens assembly <b>10</b>, the contact lens <b>12</b> may be used by itself or in assembly with the lens holder <b>18</b>. As presented in <figref idref="DRAWINGS">FIGS. 1A, 3A, and 4A</figref>, the contact lens <b>12</b> is used by itself. The contact lens <b>12</b> is equipped with the anchoring system <b>16</b> configured with microstructures <b>24</b> on the bottom <b>22</b>. The micro-pins (or other microstructures) <b>30</b> are strategically placed on the bottom <b>22</b> of the lens <b>12</b>.

As shown in <figref idref="DRAWINGS">FIGS. 3A and 4A</figref>, the lens' bottom <b>22</b> is an eye contacting surface which may be shaped as a circular arc or in another suitable curved configuration to conform with the curvature of the eye cornea <b>32</b>.

The lens <b>12</b> has the upper surface <b>48</b> spaced from the bottom surface <b>22</b> by circumferentially extending walls <b>50</b>. The walls <b>50</b> of the contact lens <b>12</b> may form a cylindrical surface, trapezoidal surface, or other contoured surface as needed for specific optical properties of the lens <b>12</b>. The upper surface <b>48</b> of the lens <b>12</b> may be smaller than, larger than, or of the same size with the surface of the bottom <b>22</b> of the lens <b>12</b> (as dictated by the needed optical properties of the lens <b>12</b>).

The contact lens <b>12</b> may be manufactured from acrylic, glass, or other bio-compatible and optically viable materials used for the contact lens.

A number of micro structured elements <b>24</b> are provided on the bottom <b>22</b> of the lens <b>12</b>. The function of the microstructures <b>24</b> is to provide friction between the bottom <b>22</b> of the lens <b>12</b> and the cornea <b>32</b> in order to prevent sliding of the lens <b>12</b> from the desired surgical site, as well as to anchor the lens in place when the microstructures <b>24</b> (for example micro-pins <b>30</b>) penetrate through the viscous solution film <b>36</b> and tear film <b>34</b> and anchored to the superficial surface of the cornea <b>32</b>.

A number of micro-pins <b>30</b> are shown on the bottom <b>22</b> of the lens <b>12</b> which constitutes an anchoring system <b>16</b>. Although the number of micro-pins <b>30</b> shown in <figref idref="DRAWINGS">FIG. 3A</figref> on the bottom <b>22</b> of the lens <b>12</b> is four, any other number greater than two may be used and is contemplated within the scope of the subject invention.

The micro-pins <b>30</b> may be manufactured from surgical steel, bio-compatible plastics or polymers, for example, PEEK (polyether ether ketone), or other bio-compatible materials.

The micro-pins <b>30</b> may be manufactured integral with the bottom <b>22</b> of the contact lens <b>12</b> (for example, by 3-D printing), or may be attached to the bottom <b>22</b> of the lens <b>12</b> via numerous mechanisms, including, for example, but not limited to, drilling, pressing, threaded engagement, thermo-soldering, coupling with the help of bonding agents (glue, adhesive), various interlocking mechanisms, such as, for example, interlocking tab and groove locking mechanism, etc. The microstructures may also be formed by chemical etching, chemical vapor deposition, plasma machining, photolithography, and other applicable processes.

For example, as shown in <figref idref="DRAWINGS">FIG. 5A</figref>, openings <b>52</b> with the threaded walls <b>54</b> are pre-machined at the bottom <b>22</b> of the lens <b>12</b> to threadingly receive the micro-pins <b>30</b>. Alternatively, as shown in <figref idref="DRAWINGS">FIG. 5B</figref>, the micro-pins can be glued in the openings <b>56</b> with glue <b>58</b> which may be, for example, a UV activated epoxy, or any other bio-compatible adhesive material.

Also alternatively to the drilling or gluing the micro-pins <b>30</b> into the bottom <b>22</b> of the lens <b>12</b>, the lens with the micro-pins (or other microstructures contemplated in the present invention for the purposes of stabilization, centralization, and prevention of the slipping of the lens from the desired surgical site) may be formed by a 3-D printer from a bio-compatible plastic, or like composition, for example, PEEK material.

The preferred diameter of the micro-pins (in their cross-section) may be in the range of 0.0012 inch, and can protrude from the surface of the bottom <b>22</b> of the lens <b>12</b> approximately 0.0013 inch to extend through the tear film <b>34</b> and viscous solution film <b>36</b> into contact with the cornea <b>32</b>. The micro-pins length from the bottom <b>22</b> to the exposed ends <b>60</b> thereof generally should not exceed 1 mm in order to prevent deep penetration into the cornea further than the corneal superficial layer.

The cross section of the micro-pins can be tapered down at the exposed ends <b>60</b> of the micro-pins <b>30</b>, or squared off.

Although shown as the same shape and same length in <figref idref="DRAWINGS">FIGS. 3A and 4A</figref>, the microstructures <b>24</b> also can be made of different shape and different dimensions, for example, as shown in <figref idref="DRAWINGS">FIG. 3B</figref>.

Referring to <figref idref="DRAWINGS">FIGS. 1B, 3B and 4B</figref>, the ophthalmic contact lens assembly <b>10</b> of the present invention includes the lens <b>12</b> and the lens holder <b>18</b>. In this arrangement, the stabilization, as well as centralization, of the ophthalmic contact lens system <b>10</b> at the desired site on the eye is provided by the anchoring system <b>20</b> configured on the bottom <b>26</b> of the lens ring holder <b>18</b>. As shown, the annular bottom surface <b>26</b> of the lens holder <b>18</b> includes microstructures in the shapes of micro-pins <b>30</b>, micro-grips, micro-barbs, micro-needles, or other textured micro-elements <b>24</b> positioned at a number of locations on the bottom <b>26</b> of the lens holder <b>18</b> around the periphery of the lens holder <b>18</b>.

The annularly shaped contact lens holder <b>18</b> has an annularly shaped bottom <b>26</b> (with concentrically spaced apart inner and outer peripheral edges) and an annularly shaped upper surface <b>62</b> (with concentrically spaced apart inner and outer peripheral edges). The circumferential outside walls <b>64</b> extend between the outer peripheral edges of the bottom surface <b>26</b> and the outer peripheral edges of the upper surface <b>62</b>.

Internal walls <b>65</b> extend between inner peripheral edges of the annularly shaped bottom surface <b>26</b> and upper surface <b>62</b>, respectively, of the holder <b>18</b>, and define a circularly shaped opening <b>66</b> therebetween.

The macular contact lens <b>12</b> is equipped with a flange element <b>68</b> which is formed integrally therewith or attached to the outer surface <b>70</b> of the circumferentially extending walls <b>50</b> of the lens <b>12</b>. The flange element <b>68</b> has a flange <b>72</b> extending from the outer surface <b>70</b> of the circumferential extending walls <b>50</b> of the lens <b>12</b>.

The bottom surface <b>22</b> of the lens <b>12</b> and the circumferentially shaped holder opening <b>66</b> of the lens holder <b>18</b> are shaped and dimensioned to correspond each to the other to permit the bottom <b>22</b> of the lens <b>12</b> to pass through the circumferentially shaped holder opening <b>66</b>. The flange member <b>68</b> is positioned around the outer surface <b>70</b> of the circumferentially extending walls <b>50</b> of the lens <b>12</b> a distance from the bottom <b>22</b> of the lens <b>12</b> corresponding to the height of the walls <b>64</b> of the lens holder <b>18</b> between the bottom surface <b>26</b> and the upper surface <b>62</b> thereof. When the contact lens <b>12</b> is received in the holder opening <b>66</b> of the lens holder <b>18</b>, the flange <b>72</b> of the flange member <b>68</b> is supported by the annularly shaped upper surface <b>62</b> of the lens holder <b>18</b>, thus preventing the contact lens <b>12</b> from displacing its bottom surface <b>22</b> below the bottom surface <b>26</b> of the lens holder <b>18</b>.

During the procedure, the lens ring holder <b>18</b> is positioned over the cornea <b>32</b>, and the lens <b>12</b> is received in the holder opening <b>66</b> of the lens holder <b>18</b>. The surgeon gently pushes down the contact lens/holder assembly <b>10</b>, so that the microstructures <b>28</b> on the bottom surface <b>26</b> of the lens holder <b>18</b> penetrate through the tear film <b>34</b> and viscous solution film <b>36</b> (as shown in <figref idref="DRAWINGS">FIGS. 1B and 2</figref>) and into the contact with superficial layer of the cornea <b>32</b> to gently indent into the cornea <b>32</b> without traumatizing the eye tissues to provide stabilization and centralization of the contact lens/holder assembly <b>10</b> in place and to prevent the deviation of the assembly <b>10</b> from the desired position during the ophthalmic procedure.

The lens ring holder <b>18</b> may be formed from polyether ether ketone (PEEK) material, or any other compound which is bio-compatible and capable of holding the contact lens <b>12</b> in position.

The height of the walls <b>64</b> of the lens holder <b>18</b> may be in the range of 1-2 mm, with the holder opening diameter ranging from 9 to 15 mm, for example, 11.5 mm.

The microstructures <b>28</b>, for example, micro-pins <b>30</b>, are formed along the circumference of the annularly shaped bottom <b>26</b> of the lens holder <b>18</b> in any manner similar to that described in previous paragraphs for the anchoring system <b>16</b> on the bottom <b>22</b> of the contact lens <b>12</b>.

A number of the micro-pins <b>30</b> on the bottom <b>26</b> of the lens holder <b>18</b> may range from 2 to 25 depending on the friction needed between the lens holder <b>18</b> and the tissues of the eye.

It has been experimentally concluded that the microstructures <b>24</b>, <b>28</b> can extend from the bottom of the lens <b>12</b> or from the bottom of the lens holder <b>18</b> no more than 1 mm in order to prevent excessive penetration and possible trauma to the surface of the tissues of the eye under surgery.

Referring to <figref idref="DRAWINGS">FIGS. 6A and 6B</figref>, as well as <figref idref="DRAWINGS">FIGS. 7A and 7B</figref>, the gonioprism assembly <b>38</b> includes a gonioprism contact lens <b>40</b> having a bottom surface <b>80</b> which is a circularly shaped surface configured to comply with the curvature of the eyeball. The gonioprism contact lens <b>40</b> has an upper surface <b>82</b> which is oval shaped and tilted as inclined with respect to the longitudinal axis <b>84</b> of the gonioprism contact lens <b>40</b>. Walls <b>86</b> extend in cylindrical contoured configuration between the edges of the bottom surface <b>80</b> and upper surface <b>82</b> of the gonioprism contact lens <b>40</b>.

The lens holder ring <b>42</b> includes an upper annularly shaped surface <b>87</b> and a bottom surface <b>88</b> which extend each from the other by a predetermined distance <b>90</b> defined by circumferentially shaped outer walls <b>92</b> of the gonioprism lens holder ring <b>42</b>. The outer walls <b>92</b> extend between the outer peripheral edges of the annularly shaped upper and bottom surfaces <b>87</b>, <b>88</b>, respectively.

The lens holder ring <b>42</b> further has inner walls <b>93</b> which extend circumferentially between inner peripheral edges of the annularly shaped upper and bottom surfaces <b>87</b>, <b>88</b>, respectively.

The inner walls <b>93</b> are contoured with a cylindrically shaped surface and define a holder opening <b>94</b> therebetween. The holder opening <b>94</b> in the lens holder ring <b>42</b> is shaped and dimensioned to correspond to the bottom surface <b>80</b> of the gonioprism contact lens <b>40</b>.

The circumferentially shaped outer walls <b>92</b> and inner walls <b>93</b> may be configured with an incision access cut-out <b>96</b> which may be a partial cut-out with a connecting element <b>98</b> extending along the edge of the upper surface <b>86</b> of the lens holder ring <b>42</b>.

Alternatively, as shown in <figref idref="DRAWINGS">FIGS. 7A and 7B</figref>, the lens holder ring <b>42</b> for the gonioprism assembly <b>38</b> may be similar to the lens holder <b>18</b> shown in <figref idref="DRAWINGS">FIGS. 3B and 4B</figref> formed as an annularly shaped lens holder with an opening <b>94</b> shaped and dimensioned for passing the bottom <b>80</b> of the gonioprism contact lens <b>40</b>.

In the arrangement shown in <figref idref="DRAWINGS">FIGS. 6A and 6B</figref>, the partial cut-out <b>96</b> is formed for surgical access/entry and visualization of the corneal incision. This cut-out <b>96</b> is positioned in relation to the site of the surgery so that the cut-out <b>96</b> is stabilized over the corneal or cataract incision. The modification of the gonioprism contact lens assembly <b>38</b> shown in <figref idref="DRAWINGS">FIGS. 6A and 6B</figref> permits the surgeon to view the incision site and to guide the surgical instrument into the anterior chamber of the eye for the ophthalmic surgery such as glaucoma surgery.

In the gonioprism assembly <b>38</b>, shown in <figref idref="DRAWINGS">FIGS. 6A-6B and 7A-7B</figref>, the bottom surface <b>88</b> of the lens holder ring <b>42</b> is provided with microstructured anchoring system <b>46</b> which, similar to that provided at the bottom <b>22</b> of the contact lens <b>12</b> and the bottom <b>26</b> of the lens ring holder <b>18</b> shown in <figref idref="DRAWINGS">FIGS. 1A-1B, 3A-3B and 4A-4B</figref>, is manufactured with microstructures <b>28</b>, described in previous paragraphs.

Referring to <figref idref="DRAWINGS">FIG. 8A</figref>, representative of the ophthalmic procedure supported by the use of the subject non-sliding, non-sutured hands-free contact lens anchoring assembly, the method begins in Step <b>1</b>, wherein the subject corneal (macular) contact lens assembly is formed which includes either the contact lens or the contact lens and the lens ring holder, where either the bottom of the lens is configured with the microstructure anchoring system or the bottom of the ring holder is configured with the anchoring microsystem. When the subject contact lens assembly is formed in Step <b>1</b>, the method advances to Step <b>2</b> where either the subject contact lens with the anchoring system on the bottom thereof, or the lens ring holder with the microstructured anchoring system on the bottom thereof is positioned above the desired surgery site on the eye.

From Step <b>2</b>, the operation follows to Step <b>3</b>, where a surgeon gently presses down either the contact lens to provide that the exposed ends of the micro-pins penetrate through the tear film and the viscous solution film, and in contact with superficial layer of the cornea.

In the procedure which uses the assembly of the contact lens and the lens ring holder, the contact lens is lowered into the opening of the lens ring holder. In both situations, the bottom of the contact lens comes into contact with the viscous solution film (when the solution is used for the procedure) or with the tear film.

In the following Step <b>4</b>, the surgeon performs the ophthalmic procedure such as vitreoretinal surgery or macular surgery. During the procedure, the subject contact lens assembly allows the surgeon to visualize the macular and other structures of the eye in high magnification. The contact lens assembly remains stabilized and centered on the cornea of the eye and is prevented from slipping from the desired surgical site.

Upon completion of the surgery procedure in Step <b>4</b>, the surgeon lifts the contact lens assembly from the eye, thus disengaging the microstructures from the tissues of the eye. The tissues of the eye are not traumatized by the micro-pins engagement therewith.

Following Step <b>5</b>, the subject assembly may be discarded (optionally) or sent for disinfection for use in other procedures.

During the Step <b>4</b>, the surgery is performed in a hands-free manner, when the surgeon (or the surgeon's assistant) does not have to manually locate and relocate the contact lens assembly. Non-sutured stabilization and centralization of the subject contact lens assembly and prevention from sliding from the desired surgical site is provided in the present method by the subject anchoring system formed at the bottom of the lens or at the bottom of the lens ring holder.

Referring to <figref idref="DRAWINGS">FIG. 8B</figref>, in Step <b>1</b>, the gonioprism assembly is formed which includes a gonioprism contact lens and the lens holder ring, where a microstructured anchoring system is formed on the bottom of the lens holder ring.

Following Step <b>1</b>, the surgeon places the lens holder ring of the gonioprism assembly on the site of the surgery, lowers the gonioprism contact lens into the holder opening of the lens holder ring, and in Step <b>3</b> gently presses the lens holder ring down into the eye so that the exposed ends of the micro-pins (or other microstructures contemplated in the scope of the present invention) penetrate through the tear film and the viscous solution film of the eye as shown in <figref idref="DRAWINGS">FIG. 2</figref>, and are in contact with a superficial layer of the eye tissue.

In Step <b>2</b>, the cut-out is positioned over the site of the corneal or cataract incision.

In the following Step <b>4</b>, the surgery (such as, for example, micro-invasive glaucoma surgery) is performed. During the surgery, the surgeon uses the subject gonioprism assembly in a hands-free manner without the need of stabilization and centralization of the gonioprism assembly by sutures. The sliding of the gonioprism assembly from the site of the surgery is prevented by the friction force provided by the microstructure on the bottom of the lens holder ring.

Upon completion of the surgery in Step <b>4</b>, the surgeon lifts the lens holder ring form the eye, thus disengaging the exposed ends of the microstructures on the bottom surface of the lens holder ring from the eye's tissues.

In Step <b>6</b>, following the removal of the gonioprism assembly from the eye, the gonioprism assembly can be optionally discarded or sent for cleaning and treatment for possible use in other procedures.

During an opthalmic procedure, it is important that that the contact lens be maintained in a stable, non-moveable positional location as the surgeon is operationally proceeding. In some cases the patient may tilt his/her head with a responsive tilting of the contact lens holder and the contact lens. This tilting causes unwanted gravitational assist forces to be applied to the contact lens and the contact lens holder which may, in some cases permit a displacement of the contact lens from the intended site.

Referring now to <figref idref="DRAWINGS">FIGS. 9-12</figref>, there is shown a speculum assembly <b>100</b> to add further stabilization and non-displaceabilty of the contact lens <b>128</b> and the contact lens holder <b>130</b> which is seen in the operational combination in <figref idref="DRAWINGS">FIG. 11</figref>.

The contact lens assembly of <b>100</b> includes a speculum of <b>104</b> seen in <figref idref="DRAWINGS">FIGS. 9 and 11</figref>. Contact lens assembly or speculum assembly <b>100</b> includes speculum <b>104</b> and stabilization mechanism <b>106</b> to be further described in following paragraphs. Speculum or eye speculum <b>104</b> may be a standard eyelid speculum used for ophthalmic procedures which is commercially available and commonly known in the art. Speculum <b>104</b> may be of the type of that is commonly known as a “Lieberman eyelid speculum”, although other speculums may be used in conjunction with stabilization mechanism <b>106</b>. For purposes of clarity and ease of understanding the “Lieberman” speculum will be used in further description.

Speculum <b>104</b> includes threaded member <b>108</b> for threaded engagement with plate member <b>118</b> of speculum <b>104</b>. Operationally, threaded member <b>108</b> may be rotationally displaced to displace threaded member <b>108</b> in a linear direction coincident with axis line <b>110</b>. A lower section (as seen in <figref idref="DRAWINGS">FIG. 9</figref>) of threaded member <b>108</b> is coupled to bracket <b>122</b> which is reversibly displaceable along axis line <b>110</b>. Bracket <b>122</b> is pivotally connected to intermediate arm members <b>124</b> positioned on opposing sides of bracket <b>122</b> as is seen in <figref idref="DRAWINGS">FIG. 9</figref>.

Intermediate arms <b>124</b> are respectively pivotally connected at pivots <b>126</b> to speculum arm members <b>112</b>. Speculum arm members <b>112</b> are pivotally coupled to plate member <b>118</b> on opposing horizontally displaced ends to permit radial displacement of speculum arm members <b>112</b> responsive to the rotation of threaded member <b>108</b>.

In this manner, rotation of threaded member <b>108</b> which is in threaded engagement with plate member <b>118</b> causes a linear displacement in axis direction <b>112</b> of bracket member <b>122</b>. Displacement of bracket member <b>122</b> being pivoted to intermediate arm members <b>124</b> which are in themselves pivoted being radially displaceable.

Loop members <b>114</b> are fixedly connected to respective speculum arm members <b>112</b> as shown. Loop members <b>114</b> are operationally used for bearing against the patient's eyelids to maintain the patient's eyelids displaced each from the other during the ophthalmic procedure. As speculum arm members <b>112</b> are radially displaced away from each other there is a respective displacement of loop members <b>114</b> away from each other. As previously described loop members <b>114</b> are adapted to contact opposing eye lids of a patient during the medical procedure and maintain the patient's eyelids in a relatively stable and spaced position.

Loop members <b>114</b> are generally wire members composed of a biocompatible solid material which has some flexibility such as stainless steel or some like composition not important to the inventive concept as herein described with the exception that loop members <b>114</b> are capable of accepting the loads imposed thereon.

Contact lens assembly <b>100</b> includes contact lens <b>128</b> which may in some cases be in the form of a geoprism lens as shown in <figref idref="DRAWINGS">FIG. 10</figref>. Contact lens holder <b>130</b> as seen in <figref idref="DRAWINGS">FIGS. 10 and 11</figref> is secured to a contact lens <b>128</b> through adhesive bonding or some other like technique. Contact lens holder <b>130</b> is fixed to contact lens <b>128</b> at least partially along a periphery of contact lens <b>128</b>. In this manner contact lens holder <b>128</b> is fixedly attached to to contact lens <b>128</b>. The function of contact lens holder <b>130</b> is to provide support and stabilization of contact lens <b>128</b> when contact lens <b>128</b> is positioned over a medical procedure site of a patient's eye.

Contact lens <b>128</b> may be of the type previously described in <figref idref="DRAWINGS">FIG. 3A-4B</figref>. Contact lens <b>128</b> may include the anchoring mechanisms previously described to retain contact lens <b>128</b> at the selected procedure site during the ophthalmic procedure. Such an anchoring mechanism as previously described may include a plurality of microstructures located on the bottom surface of wall contact lens <b>128</b>. These microstructures may be selected from the group of micro-pins, micro-grips, micro-barbs, micro-needles, textured micro-elements as well as combinations thereof.

As described, contact lens holder <b>130</b> is fixedly secured to contact lens <b>28</b> throughout or at least a portion of the periphery of contact lens <b>130</b> as is seen in <figref idref="DRAWINGS">FIG. 10</figref>. Contact lens holder <b>130</b> may be formed of a polygonal or circular cross-sectional contour tubing for matingly interfacing with contact lens <b>128</b>. As shown in <figref idref="DRAWINGS">FIGS. 10 and 11</figref> contact lens holder <b>130</b> is formed by a substantially cylindrical tubing which receives contact lens <b>128</b>. However, the particular contour of contact lens holder <b>130</b> is not important to the inventive concept as herein described with the exception that it is adhered to at least a portion of contact lens <b>128</b> in order to securely hold contact lens <b>128</b> within contact lens holder <b>130</b>. Contact lens holder <b>130</b> may be composed of a solid composition which is bio-compatible, such as stainless steel or some like composition which is substantially rigid.

As more clearly seen in <figref idref="DRAWINGS">FIG. 10</figref>, stabilization mechanism <b>106</b> includes flexible stabilization wire <b>132</b> having a stabilizing wire first ends <b>134</b> secured to contact lens holder <b>130</b> on opposing sides of lens holder <b>130</b> as is shown in both <figref idref="DRAWINGS">FIGS. 10 and 11</figref>. Stabilizing wire first ends <b>134</b> may be adhered to lens holder <b>130</b> by adhesion or some like technique with the important consideration being that lens holder <b>130</b> is secured to stabilizing wire <b>132</b> at stabilizing wire first ends <b>134</b>. When taken in combination, contact lens <b>128</b>, contact lens holder <b>130</b>, and flexible stabilizing wire <b>132</b> form a closed contour.

Stabilizing wire <b>132</b> passes through a pair of sleeve members <b>136</b> which are mounted to and on opposing sides of stabilizing wire <b>132</b> which is clearly seen in <figref idref="DRAWINGS">FIG. 10</figref>. Each of sleeve members <b>136</b> is formed of either an elastic composition such as rubber or in fact may be a formed of a bio-compatible composition which may be rigid. For purposes of illustration, sleeve member <b>136</b> is shown as being a substantially tubular contour. Sleeve members <b>136</b> are fixedly attached to stabilizing wire <b>132</b> by adhesive attachment or some like mechanism not important to the inventive concept as herein described. Each sleeve member <b>136</b> includes a respective sleeve member appendage or lug <b>138</b> extending from end of each of sleeve members <b>136</b> in the axial direction <b>110</b>. Sleeve member appendages <b>138</b> are fixedly secured to sleeve members <b>136</b> by being formed in one-piece formation with the sleeve members <b>136</b> or otherwise fixedly attached to respective sleeve members <b>136</b>.

Each end of plate member <b>118</b> is formed with a recess <b>140</b> within which respective speculum arm members <b>112</b> are pivotally connected as previously described. Thus the ends of plate member <b>118</b> take the form of a C-shape which provides a space between the speculum arm members <b>112</b> and the body of plate member <b>118</b>.

Sleeve member appendages <b>138</b> extending from an end of each of sleeve members <b>136</b> are insertable within opening or recess <b>140</b> of plate member <b>118</b> as seen in <figref idref="DRAWINGS">FIG. 12</figref>. Sleeve member appendages <b>138</b> are inserted within plate opening <b>140</b> and may be wedged within plate opening <b>140</b> or otherwise secured thereto. In one aspect of system <b>100</b>, appendages or lugs <b>138</b> are frictionally secured within recesses <b>140</b> to permit easy removal of stabilizing mechanism <b>106</b> from eye speculum <b>104</b> subsequent to the ophthalmic procedure. Stabilizing wire <b>132</b> includes stabilizing wire upper section <b>142</b> and is adapted to extent over an upper surface of plate member <b>118</b> in a direction perpendicular to axis direction <b>110</b>.

In this manner there is formed a continuous stabilizing wire <b>132</b> contour extending from stabilizing wire first ends <b>134</b> to provide a continuous stabilizing wire <b>132</b> between stabilizing wire first ends <b>134</b> as is seen in both <figref idref="DRAWINGS">FIGS. 10 and 11</figref>. Stabilizing wire <b>132</b> includes a lower stabilizing wire section which passes between loop members <b>114</b> having inner loop sections <b>116</b> as is seen in assembly in <figref idref="DRAWINGS">FIG. 11</figref>.

Operationally, when threaded member <b>108</b> is rotated, respective intermediate arm members <b>124</b> radially displace speculum arm members <b>112</b>. Stabilizing wire <b>132</b> is mounted within speculum arm members <b>112</b>, as is seen in <figref idref="DRAWINGS">FIG. 11</figref> in operational combination. Stabilizing wire <b>132</b> is thus secured to eye speculum <b>104</b> between the displacement distance of inner loop sections <b>116</b> and may be essentially independent of the displacement of speculum arm members <b>112</b>.

Stabilizing wire <b>132</b> is fabricated from a malleable material such as stainless steel, a plastic composition or some like material which can hold its shape in a stable mode, but can be bent or flexibly displaced.

In this manner during an ophthalmic procedure, contact lens holder <b>130</b> and captured contact lens <b>128</b> are lowered onto the predetermined location desired in cooperation with the eye speculum <b>104</b> If adjustments are needed to the positioning of lens holder <b>130</b>, the surgeon can simply apply pressure to a mid-section of stabilizing wire <b>132</b> to effect displacement of lens holder <b>130</b> and associated contact lens <b>128</b>. The adjustment pressure on stabilizing wire can be accomplished by the surgeon applying displacement force to the stabilizing wire <b>132</b> through the use of forceps contacting and applying pressure to opposing sides of stabilizing wire <b>132</b>.

In this manner, when a patient during a medical procedure tilts his/her head, the contact lens holder <b>130</b> and responsively the contact lens <b>128</b> are maintained in a stabilized position which acts against any gravity assist forces which may be encountered during the opthalmic procedure.

Although this invention has been described in connection with specific forms and embodiments thereof, it will be appreciated that various modifications other than those discussed above may be resorted to without departing from the spirit or scope of the invention as defined in the appended claims. For example, functionally equivalent elements may be substituted for those specifically shown and described, certain features may be used independently of other features, and in certain cases, particular locations of the elements may be reversed or interposed, all without departing from the spirit or scope of the invention as defined in the appended claims.